Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)

Phase 3

Completed

• Conditions: Atherosclerosis; Ischemia; Myocardial Infarction; Cerebrovascular Accident
• Interventions: Drug: Vorapaxar 2.5 mg; Drug: Placebo

• Registration Number: NCT00617123
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study is designed to evaluate the long-term ocular safety of SCH 530348 (vorapaxar) in participants with established atherosclerotic disease who are enrolled into the TRA 2°P - TIMI 50 Study (P04737) (NCT00526474).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-15
• Study Start: 2008-07-01
• Primary Completion: 2010-10-01
• Study Completion: 2010-10-01
• Results First Submitted: 2014-05-09
• Results First Submitted QC: 2014-07-11
• Results First Posted: 2014-07-14
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

• Evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems

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Exclusion Criteria

• The study will include participants who meet none of the exclusion criteria for the parent protocol (P04737) and also the following:

  • history or evidence of age-related macular degeneration on baseline evaluation
  • history of diabetic macular edema, or evidence of treated diabetic retinopathy on baseline evaluation
  • history or evidence of other retinal diseases, including retinal injury, on baseline evaluation
  • history or evidence of retinal surgery, including laser photocoagulation, on baseline evaluation
  • history or evidence of glaucoma on baseline evaluation
  • history or evidence of high intraocular pressure of >22 mm Hg on baseline evaluation
  • evidence of center foveal thickness of >190 µm on baseline OCT examination
  • presence of vacuoles in the retina on baseline OCT

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vorapaxar	Vorapaxar 2.5 mg	Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
Placebo	Placebo	Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Develop Vacuolization in the Inner Nuclear Layer (INL) of the Retina as Measured by Ocular Coherence Tomography (OCT)	Up to 12 months	Vacuolization is defined as the presence of more than one vacuole (defined as a clear, round structure in the INL of the retina of at least 30 microns in diameter) compared to baseline in either the left or right eye as evaluated by ocular coherence tomography (OCT).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by OCT	Baseline and 4, 8 and 12 months	Individual OCT abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 84 (42 possible abnormalities per eye). Data are for the left and right eyes combined (score range: 0 to 84). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.
Number of Participants Who Have a Decrease in Visual Acuity Score of at Least Seven Letters From Baseline	Baseline and 4, 8 and 12 months	Visual acuity was assessed in both eyes by best corrected visual acuity following standardized refraction. The best corrected visual acuity score is the number of letters on a standard visual acuity testing chart read correctly by a participant. A decrease in best corrected visual acuity score in the left and/or right eye indicates a worsening of vision.
Number of Participants With Change From Baseline of Center Foveal Thickness of Greater Than 15 Microns as Measured by OCT	Baseline and 4, 8 and 12 months	Center foveal thickness measured by OCT was evaluated for a change from baseline in greater than 15 microns in either the left or right eye.
Change From Baseline in the Numerical Score of Graded Abnormalities as Measured by Fundus Photography	Baseline and 4, 8 and 12 months	Individual fundus photography abnormalities were scored as 0=not present or 1=present. The total number of possible abnormalities present was 48 (24 possible abnomalities per eye). Data are for the left and right eyes combined (score range: 0 to 48). Change from Baseline at a given timepoint was calculated as Timepoint Score minus Baseline Score. A smaller score indicates fewer graded abnormalities.